SPL v3
SPL
SPL Set ID 62caa4a8-e7b0-4a2e-824b-861652a240ee
Route
TOPICAL
Published
Effective Date 2013-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.5 g)
Inactive Ingredients
Water Cocamidopropyl Betaine Sodium C18 Olefin Sulfonate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Trolamine Propylene Glycol Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Panthenol Phenoxyethanol Edetate Disodium Salvia Officinalis Flowering Top Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-07

Description

PURPOSE ACNE TREATMENT


Medication Information

Warnings and Precautions

WARNINGS FOR EXTERNAL USE ONLY

Indications and Usage

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration

Directions

Wet your face and gently massage facial cleanser into skin for 10 - 15 seconds, avoiding contact with eyes. Thoroughly rinse your face with lukewarm water.

  • Wash the entire affected area one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Description

PURPOSE ACNE TREATMENT

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50568-5

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Section 51727-6

Inactive Ingredients

Water, cocamidopropyl betaine, sodium olefin sulfonate, acrylate copolymer, triethanolamine, propylene glycol, polyquaternium-7, panthenol, phenoxyethanol, disodium EDTA, salvia officinalis (sage) leaf extract, citric acid, fragrance.

Section 51945-4

Section 53413-1

Questions?

1-866-404-7656 or www.exposedskincare.com

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID (0.5%)


Structured Label Content

Indications and Usage (34067-9)

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)

Directions

Wet your face and gently massage facial cleanser into skin for 10 - 15 seconds, avoiding contact with eyes. Thoroughly rinse your face with lukewarm water.

  • Wash the entire affected area one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Warnings and Precautions (34071-1)

WARNINGS FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Water, cocamidopropyl betaine, sodium olefin sulfonate, acrylate copolymer, triethanolamine, propylene glycol, polyquaternium-7, panthenol, phenoxyethanol, disodium EDTA, salvia officinalis (sage) leaf extract, citric acid, fragrance.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions?

1-866-404-7656 or www.exposedskincare.com

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID (0.5%)


Advanced Ingredient Data


Raw Label Data

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